A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Muscarinic Antagonists; Solifenacin Succinate

Criteria

Inclusion Criteria:

• Patient willing and able to complete the questionnaires

• Diagnosis of OAB

• Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:

• number of micturitions > 8/24 h or

• decrease in urgency urinary incontinence (UUI) or incontinence episodes / 24 h less than 50% or

• decrease in urgency episodes / 24 h less than 50% or

• decrease in number of micturitions / 24 h less than 20% or

• not acceptable tolerability

• Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

• History of stress incontinence

• Active urinary tract infection (confirmed by positive urine analysis)

• Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Peak urinary flow rate (Qmax) < 10ml/sc and/or Postvoid residual urine volume (PVR) > 150 ml

• Uncontrolled Diabetes Mellitus

• History of drug and/or alcohol abuse at the time of enrolment

• History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions.

• Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor

• Previous treatment with solifenacin

• Likely to participate in another study during study period of 12 months from study entry